PRINCETON, N.J., Dec. 18, 2025 /PRNewswire/ -- Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that the results from its Phase 2a proof of concept study evaluating SGX945 (dusquetide) in the treatment of Behçet's Disease have been published in Rheumatology (Oxford), in an article entitled "Results from a Pilot Study of Dusquetide fo ...

Core Insights - Soligenix, Inc. has completed a Phase 2a proof of concept study for SGX945 (dusquetide) in treating Behçet's Disease, demonstrating biological efficacy [1][5] - The study showed that SGX945 had comparable outcomes to apremilast, the only approved drug for oral ulcers in Behçet's Disease, with a 40% improvement in ulcer count compared to placebo [3][4] - SGX945 was well-tolerated with no treatment-related adverse events, contrasting with common side effects associated with apremilast [4][5] Study Design and Results - The Phase 2a study was an open-label trial involving 8 patients with mild to moderate Behçet's Disease, receiving SGX945 as a twice-weekly intravenous infusion for 4 weeks [6] - The primary endpoint was the area under the curve (AUC) for the mean number of ulcers over time, with SGX945 showing a 40% improvement compared to placebo, while apremilast showed a 37% improvement [3][4] - Improvements in oral pain were also noted, with 7 out of 8 patients reporting benefits from SGX945 treatment [4][5] Future Development Plans - The company plans to reformulate SGX945 for home-based treatment using subcutaneous injection, aiming to enhance patient convenience and compliance [5] - There is an intention to conduct a follow-on placebo-controlled Phase 2 study to further explore SGX945's benefits in Behçet's Disease [6] - The company is looking to expand dusquetide's development into other innate immune-related inflammatory conditions as part of its long-term strategy [5] Market Context - Behçet's Disease is a chronic condition affecting approximately 1 million people worldwide, with significant unmet medical needs for effective treatments [6][11] - Current treatments, including apremilast, have limitations such as high costs and side effects, highlighting the potential market opportunity for SGX945 [12]